At a session dedicated to European patient data, EHTEL member, Vincent Keunen of Andaman7 - supported by the xShare project - offered insights into new approaches towards patient data. The session took place in Copenhagen, Denmark on 2-4 February 2025 at the EUCROF conference.
EUCROF is the yearly conference of the European CRO Federation. Contract research organisations (CROs) are companies that provide contracted-out research service support to others in the life sciences sector (such as pharmaceutical, biotechnological, and medical device companies).
The conference ran some special interests streams. One was on approaches to data in the European clinical research sphere.
This session was important in associating the importance of primary and secondary uses of health data. The three presentations were very complementary to each other.
Source: EUCROF LinkedIn
“xShare and Data Portability Solutions in Europe: Implications for Clinical Research”
In his presentation, Vincent Keunen (Andaman7) discussed solutions to the lack of health data interoperability in Europe. Initiatives like the European Health Data Space (EHDS) offer hope. He explored the importance of setting and enforcing data exchange standards and the current state of affairs. He highlighted the work of promising projects such as xShare with its Yellow Button; dedicated work on the European health record framework (e.g., in Xt-EHR); and XpanDH.
“The impact of the EHDS for clinical research”
Dipak Kalra (The European Institute for Innovation Through Health Data) explained the main provisions of the European Health Data Space. The Regulation covers primary uses and secondary uses of health data in and across borders. He identified opportunities for clinical research that these provisions provide. He also described measures that key actors in the field (including pharmaceutical companies and CROs) should now take. In this way, they can promote the key success factors that need to be properly applied in the upcoming EHDS and its relevant implementing acts. (The EHDS Regulation was officially published on 5 March 2025.)
“Federated analyses & mastering heterogenous data: Implementing a scalable approach to FHIR/OMOP-compliant Common Data Models”
Nora Sagel (Honic), a German real world health data company, explored the challenges of managing heterogeneous real world data. She showed how implementing scalable approaches to FHIR/OMOP-compliant Common Data Models can unlock data's full potential for research. She provided strategies for common data models to streamline the analysis of decentralised datasets. She also shared in-depth insights on how federated analyses can improve time-to-data and support data-driven decision-making in medicine.
